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Columbus,
Ohio43210

Purpose:

The purpose of this study is to compare peoples with disease (sarcoidosis) to those without
disease. We want to see if people with sarcoidosis have a different immune response to
those people without disease.
The goal of this study is to see if the nicotine patch is an anti-inflammatory treatment for
sarcoidosis.

Study summary:

Until recently, there was no good explanation for the fact that smoking cigarettes actually
reduces the risk of sarcoidosis. Research studies have shown that the nicotine, a common
component of cigarette smoke, strongly suppresses the immune system and reduces the type of
inflammation that is characteristic of sarcoidosis in the lungs. We propose that nicotine
treatment, administered in the form of a skin patch, will reduce the severity of lung
disease in patients with sarcoidosis. Sarcoidosis patients who volunteer to participate in
this study will submit standardized questionnaires relating to their quality of life and the
severity of their shortness of breath before and after treatment. We will also compare
objective measures of lung function, radiographic parameters, and the severity of lung
inflammation. We predict that nicotine treatment will reduce the severity of sarcoidosis
symptoms, improve lung function, and resolve lung inflammation. If our hypothesis is proven
to be correct in this relatively small group of patients, we will perform additional studies
in a larger group of patients and will consider the features of sarcoidosis patients that
predict a favorable response to nicotine and other nicotine-like drugs. If nicotine is
ultimately found to be an effective treatment for sarcoidosis, it may replace some of the
existing treatments which are frequently ineffective and have unacceptable side-effects.

Criteria:

Inclusion Criteria:
- • Symptomatic (active) granulomatous lung disease (radiographic stage II or III
disease) at least 6 months after the diagnosis. This selects patients that have the
chronically active variant of sarcoidosis and will likely require long-term treatment
(33).
Exclusion Criteria:
- • Active smokers,
- Previous splenectomy,
- Those requiring high-dose immunosuppression [i.e., ≥ 0.2 mg/kg/day prednisone
(or equivalent) or > 10 mg/week methotrexate or requires second line cytolytic
agents (e.g., cyclophosphamide, azathioprine) or anti-TNF treatments (e.g.,
thalidomide, anti-TNF antibodies, etc.)] to control disease activity.
- We will also exclude patients at high risk of complications relating to the use
of nicotine. This will include patients with a known intolerance of nicotine or
those with active cardiac or central nervous system disease who are at higher
risk of cardiac arrhythmias or seizures.
- We will also exclude patients with extensive pulmonary fibrosis based upon lung
biopsy or high resolution CT scan criterion

NCT ID:

NCT00701207

Primary Contact:

Principal InvestigatorElliott D. Crouser, M.D.Ohio State University

Backup Contact:

N/A

Location Contact:

Columbus, Ohio 43210United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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